Critical Limb IschemiaBESTNCT04191746
BEST vCLI Registry
An observational study of Critical Limb Ischemia, run by Duke University at 1 site in United States.
Trial summary
For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- How many people
- 1,009 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 25 Sep 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with critical limb ischemia Phase I: While the BEST-CLI Trial is actively enrolling, the BEST-Registry will only enroll patients who first screen fail from BEST-CLI. Phase II: After BEST-CLI officially finishes enrollment, screen failure for BEST-CLI will no longer be required for enrollment into the BEST-Registry 1200 patients, across approximately 40 sites participating in BEST-CLI clinical trial.
Who may be able to join
- Male or female
- age 18 years or older
- Infrainguinal peripheral artery disease (occlusive disease of the arteries below the inguinal ligament)
- Critical limb ischemia, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6
- Documented consideration for enrollment in the BEST-CLI Trial with documented failure to meet inclusion / exclusion criteria. Phase ll After BEST CLI official enrollment ends, this inclusion criteria will be removed.
- Willingness to comply with vCLI protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Who cannot join
- Presence of a popliteal aneurysm (> 2 cm) in the index limb
- Life expectancy of less than 2 years due to reasons other than peripheral artery disease
- Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- Current chemotherapy or radiation therapy
- Pregnancy or lactation
- Administration of an investigational drug for peripheral artery disease within 30 days of randomization
- Participation in a clinical trial (except observational studies) within the previous 30 days
- Prior enrollment or randomization into the BEST-CLI trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: BEST Critical Limb Ischemia (vCLI) Registry
For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.
Read the detailed description
The study will be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.
Population: Patients over age 18 presenting with critical limb ischemia After initial enrollment at 40 study sites throughout the US. participants will complete follow-up 6 months and 12 months via call center telephone calls.
The study plan calls for enrollment of approximately 1,200 participants throughout the US that will then have 12 month followup that includes collection of medications, hospitalizations for collection of events.Additionally, the BEST-CLI trial will be gathering quality of life data and cost data using similar instruments, thus providing an opportunity for comparison between cost and quality of life analyses in a clinical trial versus in a real-world registry and collection of Quality of Life using validated instruments: EQ-5D, VASQOL, SF-12.and bill review to determine economic impact of disease.
- Conditions
- Critical Limb Ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with critical limb disease | This registry will collect data from participants with critical limb disease from Duke University and approximately 40 sites in North America. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
Number of participants in the registry with major limb events as reported by participants and confirmed by medical records
Measured: 6 months
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
Number of participants in the registry with major limb events as reported by participants and confirmed by medical records
Measured: 12 months
Secondary outcomes (20)
Number of participants that died within 30 days of index procedure
Collect composite of MALE or perioperative death within 30 days of index procedure using patient/proxy information qualified by medical records.
Measured: 30 days
Number of participants with amputation free survival as measured by patient report/verified by medical record review
Interviews completed at 6 months with participants that note no hospitalization for amputation and verified by medical records
Measured: 6 months
Number of participants with amputation free survival as measured by patient report/verified by medical record review
Interviews completed at 12 months with participants that note no hospitalization for amputation and verified by medical records
Measured: 12 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
At 6 month visit, the number of participants that did not report additional procedures such as surgery or angiography.in the affected leg
Measured: 6 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
At 12 month visit, the number of participants that did not report additional procedures such as surgery or angiography.in the affected leg
Measured: 12 months
Number of interventions per limb as measured by patient report/verified by medical record review
Interventions consist of need to be hospitalized for a form of revascularization
Measured: 6 months
Number of interventions per limb as measured by patient report/verified by medical record review
Interventions consist of need to be hospitalized for a form of revascularization
Measured: 12 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
Limb revascularization failure is loss of circulation to the limb that has procedural revascularization previously performed that is non functioning
Measured: 6 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
Limb revascularization failure is loss of circulation to the limb that has procedural revascularization previously performed that is non functioning
Measured: 12 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
Number of participants that answered no to the question "Was your hospitalization for a Heart Attack(MI) at 6 months verified by medical record.
Measured: 6 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
Number of participants that answered no to the question "Was your hospitalization for a Heart Attack(MI) at 12 months verified by medical record.
Measured: 12 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
Stroke is inclusive of a cerebral vascular including a ischemic, hemorrhagic or a TIA event.
Measured: 6 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
Stroke is inclusive of a cerebral vascular including a ischemic, hemorhagic or a TIA event.
Measured: 12 months
Number of participants that did not have a periprocedural (30 day) major adverse cardiac events as measured by patient report/verified by medical record review
Events that occur during a revascularization procedure including cardiovascular events such as Myocardial Infarction and stoke.
Measured: 6 months
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression. I also includes a 0-100 scale regarding participants assessment of health.
Measured: Baseline
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression. I also includes a 0-100 scale regarding participants assessment of health.
Measured: 6 month
Quality of life as measure by the validated QOL tool (EuroQol) that will be administered throughout the study
The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression with a range of 5 answers. I also includes a 0-100 scale regarding participants assessment of health.
Measured: 12 month
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view
Measured: Baseline
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view
Measured: 6 months
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start9 Dec 2019
- Primary completion30 Jun 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,009 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Manesh Patel, MD, Principal investigator, Duke UniversitySreekanth Vemulapalli, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191746
- Sponsor's protocol ID
- Pro00102178
- Other IDs
- 1R01HL141213-01
- Acronym
- BEST
- Status last verified
- Jun 2025
- First submitted
- 16 Apr 2019
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEST Critical Limb Ischemia (vCLI) Registry
- ClinicalTrials.gov ID
- NCT04191746
- Acronym / sponsor ID
- BEST / Pro00102178
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,009 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.
Detailed description
The study will be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.
Population: Patients over age 18 presenting with critical limb ischemia After initial enrollment at 40 study sites throughout the US. participants will complete follow-up 6 months and 12 months via call center telephone calls.
The study plan calls for enrollment of approximately 1,200 participants throughout the US that will then have 12 month followup that includes collection of medications, hospitalizations for collection of events.Additionally, the BEST-CLI trial will be gathering quality of life data and cost data using similar instruments, thus providing an opportunity for comparison between cost and quality of life analyses in a clinical trial versus in a real-world registry and collection of Quality of Life using validated instruments: EQ-5D, VASQOL, SF-12.and bill review to determine economic impact of disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with critical limb disease | – | –This registry will collect data from participants with critical limb disease from Duke University and approximately 40 sites in North America. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with critical limb ischemia Phase I: While the BEST-CLI Trial is actively enrolling, the BEST-Registry will only enroll patients who first screen fail from BEST-CLI. Phase II: After BEST-CLI officially finishes enrollment, screen failure for BEST-CLI will no longer be required for enrollment into the BEST-Registry 1200 patients, across approximately 40 sites participating in BEST-CLI clinical trial.
Key inclusion criteria (6 listed)
- Male or female
- age 18 years or older
- Infrainguinal peripheral artery disease (occlusive disease of the arteries below the inguinal ligament)
- Critical limb ischemia, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6
- Documented consideration for enrollment in the BEST-CLI Trial with documented failure to meet inclusion / exclusion criteria. Phase ll After BEST CLI official enrollment ends, this inclusion criteria will be removed.
Key exclusion criteria (8 listed)
- Presence of a popliteal aneurysm (> 2 cm) in the index limb
- Life expectancy of less than 2 years due to reasons other than peripheral artery disease
- Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- Current chemotherapy or radiation therapy
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
Time frame: 6 months
Number of participants in the registry with major limb events as reported by participants and confirmed by medical records
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
Time frame: 12 months
Number of participants in the registry with major limb events as reported by participants and confirmed by medical records
20 secondary outcomes
Number of participants that died within 30 days of index procedure
Time frame: 30 days
Number of participants with amputation free survival as measured by patient report/verified by medical record review
Time frame: 6 months
Number of participants with amputation free survival as measured by patient report/verified by medical record review
Time frame: 12 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
Time frame: 6 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
Time frame: 12 months
Number of interventions per limb as measured by patient report/verified by medical record review
Time frame: 6 months
Number of interventions per limb as measured by patient report/verified by medical record review
Time frame: 12 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
Time frame: 6 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
Time frame: 12 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
Time frame: 6 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
Time frame: 12 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
Time frame: 6 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
Time frame: 12 months
Number of participants that did not have a periprocedural (30 day) major adverse cardiac events as measured by patient report/verified by medical record review
Time frame: 6 months
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
Time frame: Baseline
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
Time frame: 6 month
Quality of life as measure by the validated QOL tool (EuroQol) that will be administered throughout the study
Time frame: 12 month
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
Time frame: Baseline
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
Time frame: 6 months
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manesh Patel, MD principal investigator
Duke University
Sreekanth Vemulapalli, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.